Scientific Basis for Ayurvedic Therapies -4

Scientific Basis for

Ayurvedic Therapies 

edited by

Brahmasree Lakshmi Chandra Mishra

3.1 Introduction

Ayurveda, the Indian System of Medicine (ISM), may be the least well known of the

complete systems of medicine in the West, despite being one of the oldest. According to

the definition used by the National Center for Complementary and Alternative Medicine

(NCCAM),

1

World Health Organization (WHO), and other organizations, Ayurveda qualifies

as a complementary and alternative medicine (CAM).

2

Certain techniques used as therapies in this system of medicine have been assimilated

in the West but not practiced as a whole system. For example, yoga, oil massages,

meditation practices, and body cleansing (both internal and external) are used frequently

in the West as part of health-promoting behaviors; they are rarely perceived as part of

a larger holistic traditional medical practice. Often the practitioners of these techniques

have not completed full Ayurvedic medical training and have merely focused on learning

the technique via the apprenticeship method. The training is limited to studies with

practitioners in India, whereas others have merely taken weekend seminars. Some

training is now available in the U.S. for those who wish to get a certificate or some other

training credential. These programs are not full time and last between 1 and 2 years.

No equivalent program of the Ayurvedic medical schools in India, which require 5

1

/

2

years of training before practice is allowed, exists.

As a result, there are quite a variety

of credentials held by the practitioners of Ayurvedic therapeutic techniques. In addition,

because licensing is not required by most states in America, there is not a consistent

and focused movement torward establishing the practice. It is also questionable as to

whether those programs that teach both professionals and paraprofessionals certain

Ayurvedic treatment techniques (e.g., yoga) without the whole context of Ayurvedic

theoretical underpinning will do more than produce isolated therapies originally

designed to be part of a whole.

This disassociation of the Ayurvedic treatment repertoire will minimize optimization of

patient recovery potential as the synergistic advantages will be lost. Because these practices

are rarely coordinated by a trained Ayurvedic physician in the West, research into the

utilization of Ayurvedic bodywork practices, cleansing, and Ayurvedic herbals used independently

or in an integrated medical scenario with allopathic treatment techniques is

essential. Research in Ayurveda must be done with rigor and with an expectation of

perusal by Western trained physicians who wish to integrate these techniques into their

health-care practices. Without research data that will convince the Western trained physician

that a patient can benefit or at least will not be harmed, Ayurveda will continue to

remain an underutilized therapeutic option for patients.

Research must be done to identify which practices and herbals are both safe for specific

conditions, with or without certain co-morbidities, and that are able to produce optimized

patient recovery. Because individual practices have begun to be used primarily

as a consumer-driven enterprise, research respecting the character and tradition of

Ayurvedic medical parameters must be conducted within the context in which the

practice is likely to occur.

3.2 Empiricism in Medical Knowledge Development

It is interesting to note that many Western-trained physicians question, for example, the

scientific underpinning or rationale for the use of Ayurvedic medicine, homeopathy, and

traditional Chinese medicine. However, empirical explanations for use of health treatments,

much like the role of empiricism in a biological lab, are often ignored as a source

of evidence. Empiricism draws upon close observation and experimentation.

So, when

past Ayurvedic physicians observed changes in a patient’s condition after administering

a treatment, it should not have been considered philosophical or traditional knowledge,

per se. It is not less valid than observations made and recorded in a laboratory experiment.

When clinical case notes are passed on to colleagues and to the next generation of doctors

being trained, it is no less valid than descriptive case studies published today in peerreviewed

medical journals. In balance, it might be helpful to note that if the highest

scientific rigor were demanded of allopathic medicine as is being demanded of CAM

practices, including Ayurveda, conventional medical practice would not meet the mark

either. In 1983 the U.S. Office of Technology stated that only 10 to 20% of all procedures

currently used in medical practice had been shown effective by controlled trial.

Clinical Research Design: Limited Systematic Review of Five Diagnostic Categories

data indicate that only 20 to 37% of procedures in conventional medicine have been

subjected to the same standards as demanded for CAM.

3.3 Ayurveda: An Evidence-Based Medicine

An accurate understanding of what evidence-based medicine (EBM) really means might

be helpful in understanding the relative role of science and clinical knowledge. EBM,

which has become a buzz word concerning medical decision making, refers to a triangulated

set of information that the physician should use to determine the best treatment for

a particular patient.

Here, Western medicine is coming closer to a holistic treatment

approach, closer to the parameters of treatment in Ayurvedic practice. The three factors

of EBM are the following:

1. Best available relevant scientific evidence concerning the effectiveness and efficacy

of the proposed treatment

2. Physician knowledge based on practice experience

3. Patient’s own preferences for treatment modalities if they do not contradict 1 or

2 above

In order to make the best utilization of this triangulation of information, physicians

must be familiar with the treatment perspectives described in the scientific literature. If

there is a dearth of information or the studies are conducted without scientific rigor,

patients are put into jeopardy; either therapies that might help will not be considered, or

physicians will be concerned about validity and reliability of data based on quality of data

in studies reported.

3.3.1 Overcoming Barriers of Research

There have indeed been barriers to CAM research, in general, which also affected

Ayurvedic research. They have included structural barriers in the West where conventional

medical institutions received the largest share of funds to investigate therapies for which

no one in the institution receiving the funds had any firsthand knowledge. Collaborations

were often not equitable, even when CAM therapists were co-investigators. Publication

bias has been a problem in the past. With specific journals dedicated to publishing CAM

literature, the situation may improve. However, both CAM investigators and journal

editors must produce and ensure the quality of data presented. In this way, those persons

who are skeptical will learn that CAM researchers can produce good, relevant science.

Expectations for randomized controlled trials (RCTs) can be another barrier. It is appropriate

for preclinical studies to be done along with quasi-experimental designs prior to

conducting RCTs whenever possible.

It is important for the investigators in RCTs to have

established factors that will allow for accurate calculation of sample size, to determine

possible sources of bias in executing such a trial, the usefulness of outcome measures

chosen, and that the dosages (if applicable) and delivery schedule of the therapeutic

product or intervention are optimized before moving to an RCT. If these factors, minimally,

are not known, then the investigators must do Phase II clinical work to establish this

information. It behooves all of us to recognize research at the case study, case series, or

outcome study level for the scientific building blocks that they are.

3.4 Research Designs: A Look at a Hierarchy of Design

Several clinical study types can be implemented by those clinicians who do not have the

funds or expertise to engage in larger research projects. These clinicians may consider

adding to the body of knowledge through executing one of the following designs.

3.4.1 Case Studies

3.4.1.1 Retrospective Case Study

This case-study design can offer information about an unusual case that might help

colleagues problem solve if they have a similar case. In this research design, there would

be no prior planning to investigate the diagnosis or treatment. The term

retrospective

is

used to refer to its structure. Generally, the authors of such a study give detailed information

about the demographic, diagnosis profile, and general health parameters of the

patient of focus. The therapy utilized and the patient progress are noted in detail. This is

a particularly useful tool when the disease presents in an unusual manner, the patient’s

progress is unanticipated, or a unique therapy has been tried.

A prospective descriptive case study is structured identically to the retrospective model

given above except that the clinician plans in advance to conduct the study. Like the

retrospective case study described above, the information is for the most part qualitative.

It is hoped that the prospective nature of the study will encourage the clinician to take

even more detailed SOAP (clinical) notes than would have been the case normally; this

creates a rich information source for those clinicians who might find the information useful

in the future. Both retrospective case studies and prospective case studies can be case

series. This change in name merely means that multiple (generally 5 to 10) patients with

a similar diagnosis or similar treatment will be presented.

Probably the most useful study of this design type is the structured or experimental

case study and case series. This design involves

a priori

design time. The specific patient

diagnostic parameters, type and duration of treatment, outcome measures, number of

patients in the sample (n = 1 to 10), and analyses would be planned in advance. This

structure allows for quantitative information in addition to the standard qualitative

information to be gleaned from the investigation. This type of design is particularly

helpful when details of the therapy and consequences are required to determine optimum

delivery of a new therapy or new combination of therapies or when there are

questions about the effectiveness of a therapy for an esoteric group of sufferers from a

particular diagnosis.

3.4.1.2 Outcome Studies

Another design that might be considered is an outcome study. This design is similar in

structure to the experimental case study described above. However, it would best be built

upon a case study where notions of percentage of improvement are available so that power

calculations could be generated. Whenever possible, knowing the number of participants

needed to show differences, generally moderate differences, is important. Otherwise,

investigators are left using cookbook guesses that may defeat the purpose of the study.

Patients serve as their own control, and their improvement is noted through standardized

measures from baseline (period just prior to treatment beginning) to various measurement

points until the end of treatment. Often 25 to 30 persons are enrolled if prior data are not

available to determine sample size needs. Because patients serve as their own control, it

is a very useful design to refine the therapy, refine study protocol, and have larger sample

size data to inform an RCT design.

Because there is no control group and patients serve as their own control (a better

match would be hard to imagine), attention to possible sources of bias in the design is

important. If covariants are known, efforts should be made to eliminate them in the

design or to collect data on these factors and control them in the analysis. This design

does not address issues of potential placebo effect; whenever possible, these studies are

followed by homogeneous and heterogeneous RCTs. Many questions that can be

answered by this design cannot be answered by RCTs. The scientific question to be asked

coupled with the data that already exist in the literature may mean that an RCT is not

the best design.

3.4.1.3 Randomized Controlled Trials

RCTs are best done when there is information in the existing literature at a quasi-experimental

level (e.g., outcome study) to inform the RCT. It is important to minimally:

1. Have a specific research question that can be answered by a multigroup comparison.

2. Know the optimum effective dose or equivalent for the medical practice before

starting.

3. Know the precise number of subjects needed to be able to detect differences among

the groups.

4. Know that the placebo or sham arm of the study will not be obvious to the

participants (blinding is maintained).

5. Know the approximate number of dropouts expected due to possible rigors of the

protocol.

6. Take precautions to control potential biases and not merely rely on random assignment

to condition or pure randomization to equally disburse individual differences

among the groups in the study.

7. Have a precise analytical plan with the person manipulating the data (biostatistician

or methodologist) blinded to group assignment as completely as the persons

in contact with the patients.

It is obvious that preliminary data at quasi-experimental levels must be collected before

the sophistication of an RCT design is cost effective. Guessing on information required to

inform an RCT will result in poor data, which may be considered valid in today’s medical

culture merely because it uses the word

randomized

in the title. It is far better to contribute

to the body of knowledge with a well-done case study or outcome study than to report

a flawed RCT.

3.4.1.4 Systematic Reviews and Meta-Analyses

Two additional designs that contribute to a consensus building about a therapy or diagnosis

are systematic reviews and meta-analyses. Both designs are secondary analyses of

previously done work. Generally, these two designs have utilized RCT data and not

included information from quasi-experimental designs with the assumption that RCTs

constitute the highest level of data collection for individual trials. Both homogeneous and

heterogeneous RCTs are used in both.

A systematic review is a qualitative method of evaluation of a group of RCTs on a

specific therapy or diagnosis for the most part. The fewer the RCTs, the smaller the data

pool from which conclusions are drawn. Currently, systematic reviews in CAM suffer

from too few RCTs on the topic, design flaws of the RCTs (e.g., inadequate sample size),

and changing expectations of expected research rigor in CAM during the most recent past.

Other levels of data must continue to be relied upon for clues to prescribing and safety

parameters.

A meta-analysis is difficult at this point, but some have been attempted. This research

strategy is similar to systematic reviews except that the analysis is a quantitative one. The

authors of such analyses generally attempt to get raw data from authors of RCTs, normalize

the data across the trials they have collected, and use this pooled data attempt to determine

the overall safety or efficacy of a particular therapy. This is even a more difficult task than

a Systematic Review strategy. These designs are best left to biostatisticians or methodologists

at this time. Even they have difficulty getting sufficient information in which to

conduct a meta-analysis, as the total information required is rarely reported in full in a

published article.

3.5 Southern California University Research Model

The authors of this chapter have pursued a stepwise approach to development of a research

track in Ayurveda, just as in other medical treatment modalities. Even though effectiveness

and efficacy of certain therapies were established via traditional knowledge and through

clinical data used in conventional medicine, this research group has chosen to investigate

Ayurvedic therapies holistically and to investigate specific herbals within a reductionistic

science-based approach as well. Animal work concerning mechanism of action and safety

and toxicity has been conducted with standard models. Additionally, each diagnosis and

therapy pursued are first tested in a structured case study design, a case series, and

outcome study before moving onward to an RCT. In this way, the team utilizes the

traditional knowledge base to develop the research questions and design both basic science

and clinical studies. Design structure and outcome measures are then used that will satisfy

scientists regardless of the continent on which they live.

Unlike their knowledge of recently formulated conventional drugs, these authors have

the advantage of knowing the long history of use of many of the herbal formulas or

processes in Ayurveda. However, we still collect adverse event data and report them (lack

of them) so that those physicians who read the studies will have as much detail as possible

about the potential benefit to their patients. Until there are many fully trained Ayurvedic

physicians in the West, access to knowledge about the appropriate use of therapies and

formulas may have to come from doctors initially trained in the West. It is best that we

become “bilingual”: Ayurvedic medical benefits should be presented both in the context

of Ayurvedic practice and in a framework that the conventional physician will understand

and ultimately feel comfortable using in his or her practice with appropriate patients.

3.6 Review of Quasi-Experimental Data

The clinical trial data in five monographs on epilepsy,

11

asthma,

12

hyperlipidemia,

13

urinary

diseases,

14

and liver diseases

15

generated by Central Council for Research in Ayurveda

and Siddha, Ministry of Health, India, were reviewed and analyzed in this chapter for

effectiveness of the following herbs and herbal formulas:

1. AYUSH 65 in epilepsy

2.

Naradeeya lakshmi vilasa rasa

in bronchial asthma

3.

Shwasa kesari

tablets in bronchial asthma

4.

Guggulu

in hyperlipidemia (short-term study)

5.

Guggulu

in hyperlipidemia/hyperlipoproteinemia (long-term study)

6.

Varuna

in urinary tract infection, benign prostatic hyperplasia (BPH), urolithiasis,

and miscellaneous disorders

7.

Kulattha

in urolithiasis

8.

Varuna

and

Kulattha

in urolithiasis

9.

Kulattha

and

Gokshuru

in urolithiasis

10.

Katuki

in hepatocellular jaundice, chronic hepatitis, and cirrhosis

11.

Katukyadi

yoga in hepatocellular jaundice, chronic hepatitis, postinfective hepatitis,

obstructive jaundice, chronic cholecystitis, and postcholecystectomy syndrome

12.

Kumariasava

in hepatocellular jaundice, chronic hepatitis, and obstructive jaundice

13.

Kumariasava

in hepatocellular jaundice, chronic hepatitis, and obstructive jaundice

14.

Daruharidra

in hepatocellular jaundice, chonic hepatitis, postinfective hepatitis,

and obstructive jaundice

3.6.1 Clinical Data

(1) quality assessment of the data using the Singh Scale for quasi-experimental designs

and (2) safety assessment using the Safety Assessment Score for Controlled Clinical Trials

©

(SAS-CT). The Singh Q-E Quality Assessment Scale

©

scores 10 factors with 15 possible

points. The 10 areas are the following:

1. Background and significance of literature review

2. Adequacy of treatment

3. Power calculation

Table 3.1 shows the rating of the data included in the monographs along two parameters:

4. Description of product and procedure

5. Description of sample selected

6. Description of outcome measures

7. Data report

8. Attention to possible bias in experimental design

9. Bias present in design or operationalization of design

10. Comparison of dropouts and competitors

Of the factors listed, 1, 2, 3, 5, and 6 have two points possible due to the specific

the SAS-CT system which queries six global issues with subfactors being scored to produce

a possible point score of 100. As the clinical trials reviewed here were not controlled, the

scores were modified for the safety assessment. Full scores were given if the scoring

category was satisfied for the single group receiving the therapy. Table 3.1 gives both

summed scores for each data set reviewed within the monograph for both scales and gives

partials across factors for all data sets reviewed.

All authors and three research assistants acknowledged here participated in the systematic

review process using both scales. Each article was primarily reviewed by two people

with a third person as an arbitrator for reconciliation purposes. This mechanism guaranteed

that four to five people reviewed each article in order to produce the scoring offered

in the table.

The studies reviewed here with the Singh Q-E Quality Assessment Scale received full

points on the factors of the background and significance of study, sample description,

clarity of outcome measures utilized, and clarity of tables and data reported. Twelve of

thirteen data sets utilized outcome measures with established, known, or reported reliability

and validity. Ten of the thirteen articles were believed to be without operationalization

flaws and presented the protocol in sufficient detail to allow for replication. Nine

of the data sets optimized treatment to patients and seven of the thirteen justified the

dosage of herbal treatments or therapies offered. Overall, this is quite a good showing.

These results should encourage others to read the literature that is originating in India

and other non-Western venues with the attitude that the data presented are going to be

consistent with the quality of trials available in the West.

The SAS-CT scores were a bit more mixed. This factor is important, because people in

the West are particularly interested in safety information on herbals and procedures that

are less well known to them. Of the 13 studies reviewed, the range of scores was from 0

to 100. Four studies got perfect scores for reporting safety issues and five got no points.

Other scores were 17, 21, 44.1, 47, and 88. It must be noted that an investigator should

address the issues around safety: the occurrence of adverse events, the severity of them

should they occur, whether they are likely related to the trial or not, and what the dropout

rate is and were these due to adverse events minimally. For example, it is impossible to

tell whether five articles did not report adverse events because none occurred, or the

information was merely not reported. A simple sentence saying (1) that there were no

adverse events and (2) there were no dropouts would go a long way to assist those reading

data to assess safety. A reader cannot assume that a product is safe if there is nothing

about adverse events mentioned; he or she can only wonder.

subfactors listed (see Table 3.1 for more details). The safety score was derived by using

TABLE 3.1

Evaluation of Clinical Trials of Typical Ayurvedic Therapies

Quasi-Experimental Designs:

Singh's Scale

Factors and Study Codes*

EPI ASTH 1

ASTH

2

LIPID

1 LIPID 2 VARUNA

KUL

A

V+

K

K+

G

KATUK

I KYOGA ASAV

DAR

U MEAN

Background and significance or

literature review

Adequate knowledge of disease 1 1 1 1 1 1 1 1 1 1 1 1 1 1

Adequate knowledge of treatment 1 1 1 1 1 1 1 1 1 1 1 1 1 1

Adequacy of treatment

Optimum dose, duration 1 1 1 1 1 0 0 0 0 1 1 1 1 0.69

Dose justification 1 1 1 0 0 0 0 0 0 1 1 1 1 0.53

Power calculation

Number needed reported 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Sufficient number recruited 0 0 0 1 1 0 0 0 0 1 1 0 0 0.3

Description of product and procedure

Sufficient for replication 1 1 1 1 1 1 0 0 0 1 1 1 1 0.76

Description of sample selected

Demographics 1 1 1 1 1 1 1 1 1 1 1 1 1 1

Diagnosis-related information 1 1 1 1 1 1 1 1 1 1 1 1 1 1

Outcome meaasures

Clearly stated 1 1 1 1 1 1 1 1 1 1 1 1 1 1

Validity and reliability established 0 1 1 1 1 1 1 1 1 1 1 1 1 0.92

Data reported

Report consistent with data tables

etc.

1 1 1 1 1 1 1 1 1 1 1 1 1 1

Attention to possible biases 0 0 0 1 1 1 0 0 0 0 1 1 1 0.46

No operationalization flaws 1 1 1 1 1 1 1 1 1 0 1 0 0 0.76

Comparison of dropouts vs.

completers

0 0 0 1 1 0 0 0 0 0 0 0 0 0.15

Total 10 11 11 13 13 10 8 8 8 11 13 11 11 10.46

TABLE 3.1 (continued)

Evaluation of Clinical Trials of Typical Ayurvedic Therapies

Factors and Study Codes*

SAS-CT (Safety Assessment Scores

for Controlled Clinical Trials) EPI ASTH 1

ASTH

2

LIPID

1 LIPID 2 VARUNA

KUL

A

V+

K

K+

G

KATUK

I KYOGA ASAV

DAR

U MEAN

AEs NR (adverse events not related) 27.0 0.0 27.0 27.0 27.0 0.0 0.0 0.0 0.0 0.0 0.0 27.0 27.0 12.5

ADRs (adverse drug reactions) 27.0 0.0 0.0 27.0 27.0 0.0 0.0 0.0 0.0 17.0 21.0 27.0 27.0 13.3

SAEs NR (serious adverse events not

related)

13.5 0.0 0.0 13.5 13.5 0.0 0.0 0.0 0.0 0.0 0.0 13.5 13.5 5.2

SADRs (serious adverse drug

reactions)

13.5 0.0 13.0 13.5 13.5 0.0 0.0 0.0 0.0 0.0 0.0 13.5 13.5 6.2

DOs AEs/SAEs NR (dropouts due to

AEs and SAEs NR)

3.5 0.0 3.5 9.5 9.5 0.0 0.0 0.0 0.0 0.0 0.0 9.5 9.5 3.5

DOs ADRs/SADRs (dropouts due to

ADRs and SADRs)

3.5 0.0 3.5 9.5 9.5 0.0 0.0 0.0 0.0 0.0 0.0 9.5 9.5 3.5

Total 88.0 0.0 47.0 100.0 100.0 0.0 0.0 0.0 0.0 17.0 21.0 100.0 100.0 44.1

*Study codes:

EPI = Effect of AYUSH 65 in epilepsy.

ASTH 1 = Effectiveness of

Naradeeya Lakshmi vilasa rasa

in bronchial asthma.

ASTH 2 = Effectiveness of

Shwasa kesari

tablets in bronchial asthma.

LIPID 1 = Effectiveness of

Guggulu

in hyperlipidemia (short-term study).

LIPID 2 = Effectiveness of

Guggulu

in hyperlipidemia/hyperlipoproteinemia (long-term study).

VARUNA = Effectiveness of

Varuna

in urinary tract infection, BPH, urolithiasis, and miscellaneous disorders.

KULA = Effectiveness of

Kulattha

in urolithiasis.

V+K = Effectiveness of

Varuna

and

Kulattha

in urolithiasis.

K+G = Effectiveness of

Kulattha

and

Gokshuru

in urolithiasis.

KATUKI = Effectiveness of

Katuki

in hepatocellular jaundice, chronic hepatitis, and cirrhosis.

KYOGA = Effectiveness of

Katukyadi

yoga in hepatocellular jaundice, chronic hepatitis, postinfective hepatitis, obstructive jaundice, chronic cholecystitis, and postcholecystectomy syndrome.

ASAV = Effectiveness of

Kumariasava

in hepatocellular jaundice, chronic hepatitis, and obstructive jaundice.

DARU = Effectiveness of

Daruharidra

in hepatocellular jaundice, chonic hepatitis, postinfective hepatitis, and obstructive jaundice.

Acknowledgments

The following research assistants participated in the systematic review process but did

not participate in manuscript preparation: Xiao-Dong Liu, Ph.D., Tarek Adra, Pharm.D.,

Carol Cho, B.Sc., and Chintan Acharya.

References

1.

2.

of a WHO Meeting, Technical Report Series 622

, Geneva, Switzerland, 1978.

3. Svoboda, R.E. and Bhattacharya, B., Ayurveda, in

Complementary and Alternative Medicine

Secrets: Questions & Answers about Integrating CAM Therapies into Clinical Practice

, Kohatsu, W.,

Ed., Hanley & Belfus, Philadelphia, 2002, p. 65.

4.

7, 2002.

5. Smith, R., The ethics of ignorance,

J. Med. Ethics

, 18, 117–118, 1992.

6. White, A. and Ernst, E., The case for uncontrolled clinical trials: a starting point for the evidence

base for CAM,

Complement Ther. Med

., 9(2), 111–116, June 2001.

7. Imrie, R., The evidence for evidence based medicine,

Complement Ther. Med

., 8, 123–126, 2000.

8. Sackett, D.L., Rosenberg, W.M.C., Gray, J.A.M., et al., Evidence-based medicine: what it is and

what it isn’t,

Br. Med. J.

, 312, 71–72, 1996.

9. Linde, K. and Jonas, W.B., Evaluating complementary and alternative medicine: the balance

of rigor and relevance, in

Essentials of Complementary and Alternative Medicine

, James, W.B. and

Levin, J.S., Eds., Lippincott–Williams & Wilkins, Philadelphia, 1999, p. 57.

10. Singh, B.B. and Berman, B.M., Research issues for clinical designs,

Complement Ther. Med.,

5,

3, 1997.

11.

Ayush-56: An Ayurvedic Anti-Epileptic Drug

, Central Council for Research in Ayurveda and

Siddha, Ministry of Health & Family Welfare, Government of India, New Delhi, 1997.

12. Goyal, H.R., Ed.,

Tamaka Shwasa (Bronchial Asthma): A Clinical Study New Delhi

, Central Council

for Research in Ayurveda and Siddha, Ministry of Health & Family Welfare, Government of

India, New Delhi, 1997.

13. Malhotra, S.C., Ed.,

Pharmacological & Clinical Studies of Guggulu (Commiphora Wightii) in

Hyperlipidaemia/Lipid Metabolism

, Central Council for Research in Ayurveda and Siddha, Ministry

of Health & Family Welfare, Government of India, New Delhi, 1992.

14. Singh, L.M., Shukla, J.P., and Deshpande, P.J.,

Management of Mutramari (Urinary Calculi) by

Three Ayurvedic Drugs: Varuna, Kulattha, and Goksuru

, Central Council for Research in Ayurveda

and Siddha, Ministry of Health & Family Welfare, Government of India, New Delhi, 1987.

15. Singh, G. and Chaturvedi, G.N.,

Clinical Studies on Kamala (Jaundice) and Yakrt Rogas (Liver

Disorders) with Ayurvedic Drugs

, Central Council for Research in Ayurveda and Siddha, Ministry

of Health & Family Welfare, Government of India, New Delhi, 1988.

What is Complementary & Alternative Medicine?, http://www.nccam.nih.gov/health/

World Health Organization, The promotion and development of traditional medicine, in Report

4

Panchakarma Therapy in Ayurvedic Medicine

Ajay Kumar Sharma

4.1 Introduction

One of the fundamental concepts of Ayurvedic management of diseases is to eliminate

toxic materials (vitiated

dosas

) from the body in order to cure a disease.

Panchakarma therapy

(PKT) is designed to eliminate the toxic materials. It is postulated that the toxic materials

of the body need to be eliminated radically before a palliative therapy is given. The

palliative therapy in the form of drugs and diets may not be effective unless the body

channels are properly cleansed and toxic materials are eliminated.

PKT is believed to purify or cleanse all the body tissues and to bring about the harmony

of neurohumours (

tridosas

)

(i.e.,

vata, pitta, kapha,

and

manasa dosas

[i.e.,

satva, raja,

and

tama

])

and to obtain long-lasting beneficial effects. PKT is not merely a therapeutic regi-

© 2004 by CRC Press LLC

44

Scientific Basis for Ayurvedic Therapies

men, but it may be considered a management tool when used at certain tissue and body

parts. It promotes and preserves the individual’s normal health.

PKT

1–3

is an important component of Ayurvedic management of diseases. It is the

comprehensive method of internal purification of the body through emesis (

vaman karma

),

purgation (

virechana karma

), enema (

vasti karma

), errhines (

nasya karma

), and bloodletting

(

raktamokshana

). This chapter will review the ancient classical concepts, traditional practices,

and recent advances made in this important field with proper evaluation and rational

assessment. Evidence obtained at our hospitals and at other research institutes in treating

a variety of diseases with PKT is discussed along with its possible use as an adjunct to

allopathic therapies.

PKT is indicated in arthritis, paralysis, neuromuscular diseases and in respiratory, gastrointestinal,

ENT, and several blood-related disorders with great benefits. PKT is contraindicated

in certain conditions like acute fevers, in various debilitating diseases, and

in certain tumors and cancers of different organs; it is also contraindicated in children,

the elderly, and pregnant women. PKT is indicated for both the healthy and diseased. The

five elimination procedures are usually advised in the sequence of emesis, purgation,

enema, errhines, and bloodletting, although it is not mandatory. Either one or all five

procedures are advised as per the need and condition of the person undergoing PKT.

Based on the health of the individual and stage and type of the disease, only one of the

five procedures may be done without following a sequence. However, proper preparation

and follow-up treatment are implemented for even one cleansing procedure.

The classical PKT is done in three stages:

1. Preparatory procedures (PREP) (

purva

karma

) — These procedures are done to

prepare the body to undergo a proper and thorough cleansing. They involve

applying as well as ingesting oils and fats, sweating, and also advising which

herbs to use to improve the digestion and metabolism in tissues.

2. Main cleansing procedures (MCP) (

pradhana

karma

) — These procedures consist

of five purification procedures especially designed to eliminate toxic materials

from the imbalanced dosas of the body. They are emesis, purgation, enema,

errhines, and bloodletting.

3. Postprocedures (

pashchata

karma

) — These procedures consist mainly of recuperative

measures in the form of diet, lifestyle changes, and rejuvenating herbs.

4.2

Panchakarma

Therapy Procedures

4.2.1 Preparatory Procedures

4,5

PREP are used to facilitate PKT effectiveness. They include (1) digestive juice stimulants

(

dipana

),

(2)

digestant (

pachana

),

(3) oleation

(

snehana

), and (4) sudation (

swedana

). All

procedures are discussed below

.

4.2.1.1 Digestive Juice Stimulants (Dipana) and Digestants (Pacana)

Digestive juice stimulants are agents that directly stimulate biofire (

agni

) and allow undigested

food to be processed without stimulating digestive enzymes. Administration of

© 2004 by CRC Press LLC

Panchakarma Therapy in Ayurvedic Medicine

45

digestants and digestive juice stimulants is an essential prerequisite of PKT; the objective

is to improve the digestion both at the cellular and gastrointestinal tract level.

Normal digestion is achieved with the administration of medicated dehydrated butter

(

ghee

) mixed with digestants and digestive juice stimulants. Dehydrated butter is a potent

biofire stimulant agent. Commonly used digestants and digestive juice stimulants are

described in Table 4.1.

Any preparation is usually administered for 3 to 7 days, depending on the age, disease,

and condition of the patient. Signs and symptoms of satisfactory stimulation of digestion

are (1) feeling of lightness in the body, (2) improved appetite, (3) feeling of thirst, and (4)

well-formed stool without any mucus.

4.2.1.2 Oleation Therapy (Snehana Karma)

4,5

Any procedure or substance that increases the availability of lubricants, which produce

lubrication in the body externally or internally, is called oleation therapy (OT). It is often

used as an independent therapeutic procedure for disorders of

vata

as well as PREP for

PKT. It is essential to administer OT to an individual before subjecting him or her to MCP

to mobilize the toxic materials from their respective sites.

OT may be given externally by applying the oily materials on the skin or internally via

ingestion, enema, or nasal route. External application consists of massage, application as

a thin layer on the skin, application on the scalp, as ear drops, holding the oily material

in the mouth for a few minutes, applying on the feet, etc.

4.2.1.2.1 Classification of Oleating Drugs and Agents

OT materials may be of animal or vegetable origin. Examples of animal origin materials

include dehydrated butter, animal fat, bone marrow, fish oil, and milk. Vegetable origin

materials include sesame oil and mustard oil.

The oleation substance selected for administration to the patient on the basis of a

water in the prescribed dose as indicated in Table 4.3.

OT is indicated prior to sudation as PREP, dry skin,

vata

dominance, excessive loss of

blood, and eye disorders. It is contraindicated in patients with aggravated

kapha

and all

conditions where PKT is contraindicated.

Internally medicated ghee is given for 3 to 7 days at the break of dawn (6 to 7

A

.

M

.),

based on the person's constitution and digestive power (

agni

and

kostha

). Usually this is

TABLE 4.1

List of Commonly Used Digestants and Digestive Stimulant Drugs

No. Formula Name Dose References

1

Panchakoladi churna

1–3 g BR

a

30/35

2

Hingvasshtaka churna

1–3 g BR 10/59

3

Lavana bhaskara churna

1–3 g BR 10/79–87

4

Chitrakadi vati

500 mg to 1 g BR 8/26,27

5

Arka vati

500 mg to 1 g BR 857

6

Agnitundi vati

250–500 mg BR 10/93,94

7

Shunthi ghrita

20–50 g BR 29/200, 201

8

Pippalyadi ghrita

20–50 g BR 5/1319–1322

9

Dashmoolarishta

20–30 ml BR 74/357–371

10

Drakshasava

20–30 ml BR 8/170–174

a

BR = Bhaishajaya Ratnavali.

underlying disease is shown in Table 4.2. Some standard preparations used for internal

oleation are listed in Table 4.3. These are to be swallowed orally with lukewarm milk or

© 2004 by CRC Press LLC

46

Scientific Basis for Ayurvedic Therapies

preceded with easily digestible and compatible food with plenty of fluids a day earlier in

order to obtain proper oleation.

4.2.1.2.2 Massage Therapy (External Oleation Therapy)

External OT is achieved through massage and is done all over the body. For massaging

the head, cold or lukewarm oil should be used. The rest of the body should be massaged

with lukewarm oils. Massaging the body is to be done from 15 to 35 min. The massage

should be carried out in seven different postures:

1. Sitting posture with extended legs

2. Lying down in supine posture

3. Lying down in left lateral position

4. Lying down on the front side of the body (over the back region)

TABLE 4.2

Selection of Oleating Materials Based on Underlying Diseases

No. Oleating Drug Disease Indicated

1

Tikta ghita, mahatikta ghita

, or

vasa ghita

Skin and blood disorders

2

Kalyana ghita, brahmi ghita, mahakalyana ghita

Mental disorders, epilepsy, insanity, etc.

3

Maha sneha, pancatikta ghita

Paraplegia

Note: Adjuvants are recommended along with oleating materials.

No. Adjuvant Oleating Material

1 Lukewarm water In all types until specified; otherwise,

dehydrated butter

2 Vegetable soups Oils

3 Gruel made of rice Fat, bone marrow

TABLE 4.3

Some Standard Preparations of Internal Oleation

No. Disease Oil/Dehydrated Butter Dose Reference

1 Bronchial asthma

Manhanshiladi ghrita

20–30 ml CC

a

17/145

2 Skin disease

Mahatikta ghrita

20–30 ml CC 7/144–150

3 Psychosis

Mahakalyanaka ghrita

20–30 ml CC 9/42–44

4 Epilepsy

Panchagavya ghrita

20–30 ml CC 10/17

5 Cardiovascular accident

(stroke)

Bala taila

20–30 ml CC 28/148–156

6 Osteoarthritis, arthritis

Eranda taila

20–30 ml CD

b

25/6

7 Hepatobiliary disorders

Draksha ghrita

20–30 ml BR

c

12/135

8 Irritable bowel syndrome

Shunthi ghrita

20–30 ml BR 8/555

9 Gynecological disorders

Phala ghrita

20–30 ml BR 67/74-77

10 Tuberculosis

Pipali ghrita

20–30 ml BR 14/237

11 Hemorrhagic diathesis

Vasa ghrita

20–30 ml CC 4/88

12 Hemorrhoids

Vyoshadya ghrita

20–30 ml BR 8/187

13 Anemia

Pathya ghrita

20–30 ml CC 16/50

a

CC =

Charak Chikitsa

.

b

CD =

Chakradatta

.

c

BR =

Bhaishajaya Ratnavali

.

5. Lying down in right lateral position

6. Lying down in supine posture

7. Sitting postures with extended legs from 2 to 5 min in each posture, depending

upon the underlying disease

The massage should be done in a downward direction (i.e., away from the heart) over

larger areas or big organs and in circular form over joints or the lower back.

Proper and regular practice of massage therapy results in the following benefits:

1. Improves eyesight

2. Induces sound sleep

3. Improves the quality of skin by making it tender, delicate, and strong

4. Corrects stiffness, rigidity, and induces elasticity in the body by softening the

muscles, ligaments, and tendons

5. Relieves exertion, tiredness, and weakness due to various physical activities

6. Relieves and controls vitiated

vata dosa

in the body

7. Delays the aging process and strengthens the body

Massage therapy produces all these effects by lubricating the microcirculatory channels,

displacing the exudates which may relieve tension and pain, and preparing smooth passages

(microchannels) for elimination of toxic materials during sudation therapy.

The standard preparations used for massage therapy are described below:

1. Oils used for head massage

a.

Candanadi taila

(Bhaishajaya Ratnavali [BR] 14/292–295)

b.

Brahmi taila

c.

Jyotismati taila

2. Oils used for body massage

a.

Vatika

disorders

i.

Narayana taila

(Chakradatta [CD] 22/120–130)

ii.

Bala taila

(BR 26/273–283)

iii.

Dasmula taila

(BR 65/89)

b.

Paittika

disorders

i.

Kshira Bala taila

ii. Candanadi taila

iii. Candan Balalaksadi taila

c. Kaphaja disorders

i. Sahacaradi taila (BR 61/134–135)

ii. Dasmula taila

Oleating materials given alone without any other carrier substances are also effective

in providing oleation. In certain cases, some other substances such as rice, fruit juices,

soup, curd, buttermilk, and lentils are added.

 

Om Tat Sat

                                                        

(Continued...) 

(My humble salutations to H H Maharshi ji,  Brahmasri Sreeman Lakshmi Chandra Mishra ji and other eminent medical scholars and doctors   for the collection)